Perioperative intravenous insulin, GIK or GLP-1 treatment in DM
- Conditions
- Patients with diabetes mellitus type 2 who will undergo non-cardiac surgeryMedDRA version: 19.0Level: PTClassification code 10058829Term: Elective surgerySystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 19.0Level: LLTClassification code 10049746Term: Insulin-requiring type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2012-005291-34-NL
- Lead Sponsor
- AMC, Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•Signed informed consent
•known diabetes mellitus type II for > 3 months
•aged 18-85 years
•scheduled for elective non-cardiac surgery
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 215
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
•Oral corticosteroid use
- use > 1 IU/kg insulin for diabetes treatment
•Planned for day-care (ambulant) surgery
•Planned ICU stay post-operatively
•History of chronic pancreatitis or idiopathic acute pancreatitis
•Impaired renal function defined as serum-creatinine = 133 µmol/L for males and = 115 µmol/L for females
•Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
•Known or suspected allergy to trial product(s) or related products
•Any condition that the local investigator feels would interfere with trial participation or the evaluation of results
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method